A lance is provided for puncturing skin and producing a sample of blood. The lance comprises a spring having a first end and a second end disposed between a needle and a base wherein the first end of spring is coupled to the base and the second end of the spring is coupled to the needle.
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1. A test sensor for use in the determination of the concentration of a chemical in blood, the test sensor comprising:
a front and a rear panel; a substantially flat test chamber disposed between the front and rear panels having an inlet, the test chamber being adapted to collect a sample of blood through the inlet; and a substantially flat lance coupled to one of the front and rear panels, the lance being adapted to puncture skin.
7. A lance comprising:
a substantially flat base; a substantially flat spring having a first end and a second end, the first end of the spring being attached to the base; a substantially flat, generally U-shaped body having an interior edge and an exterior edge, the interior edge of the U-shaped body coupled to the second end of the spring, the generally U-shaped body having two sides for receiving an external force providing movement to the U-shaped member; and a substantially flat needle attached to the exterior edge of the U-shaped body; wherein, the base, the spring, the U-shaped body, and the needle are made out of a single piece of a material.
11. A blood glucose monitoring system comprising:
a substantially flat test sensor having an inlet for receiving a blood sample; a substantially flat lance having a substantially flat base, a substantially flat spring, and a substantially flat, generally U-shaped body, the spring having first and second end, the first end being attached the base, the U-shaped body having an interior edge attached to the second end of the spring and an exterior edge, the lace having a substantially flat needle outwardly extending from the exterior edge of the U-shaped body for puncturing a user's skin; and a forcing member providing movement to the needle of the lance in a first direction by contacting the U-shaped body, the spring retracting the flat lance in a second direction.
2. The test sensor of
a spring having a first end and a second end, the first end coupled to the test sensor; and a needle coupled to the second end of the spring.
3. The test sensor of
a base; a thin spring having a first end and a second end, the first end coupled to the base; a thin, generally U-shaped body having an interior edge and an exterior edge, the second end of the thin spring coupled to the interior edge; and a thin needle coupled to the exterior edge.
4. The test sensor of
5. The test sensor of
9. The lance of
10. The lance of
12. The system of
13. The system of
14. The system of
15. The system of
16. The system of
18. The system of
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This application claims the benefit of Provisional application No. 60/216,972, filed Jul. 10, 2000.
The present invention relates generally to blood monitoring devices, and, more particularly, to a thin lance and a test sensor having the same for obtaining a sample of blood.
It is often necessary to quickly obtain a sample of blood and perform an analysis of the blood sample. One example of a need for painlessly obtaining a sample of blood is in connection with a blood glucose monitoring system where a user must frequently use the system to monitor the user's blood glucose level.
Those who have irregular blood glucose concentration levels are medically required to regularly self-monitor their blood glucose concentration level. An irregular blood glucose level can be brought on by a variety of reasons including illness such as diabetes. The purpose of monitoring the blood glucose concentration level is to determine the blood glucose concentration level and then to take corrective action, based upon whether the level is too high or too low, to bring the level back within a normal range. The failure to take corrective action can have serious implications. When blood glucose levels drop too low--a condition known as hypoglycemia--a person can become nervous, shaky, and confused. That person's judgment may become impaired and that person may eventually pass out. A person can also become very ill if their blood glucose level becomes too high--a condition known as hyperglycemia. Both conditions, hypoglycemia and hyperglycemia, are both potentially life-threatening emergencies.
One method of monitoring a person's blood glucose level is with a portable, hand-held blood glucose testing device. A prior art blood glucose testing device 100 is illustrated in FIG. 1. The portable nature of these devices 100 enables the users to conveniently test their blood glucose levels wherever the user may be. The glucose testing device contains a test sensor 102 to harvest the blood for analysis. The device 100 contains a switch 104 to activate the device 100 and a display 106 to display the blood glucose analysis results. In order to check the blood glucose level, a drop of blood is obtained from the fingertip using a lancing device. A prior art lancing device 120 is illustrated in FIG. 2. The lancing device 120 contains a needle lance 122 to puncture the skin. Some lancing devices implement a vacuum to facilitate the drawing of blood. Once the requisite amount of blood is produced on the fingertip, the blood is harvested using the test sensor 102. The test sensor 102, which is inserted into a testing unit 100, is brought into contact with the blood drop. The test sensor 102 draws the blood to the inside of the test unit 100 which then determines the concentration of glucose in the blood. Once the results of the test are displayed on the display 106 of the test unit 100, the test sensor 102 is discarded. Each new test requires a new test sensor 102.
One problem associated with some conventional lancing devices is that the user who regularly self-tests is required to carry at least two instruments--a lance and a test unit. This places a greater burden on the user to remember to carry as well as to maintain two separate devices. Further, a greater amount of space is occupied on the user's person. There can also be an increased expense associated with two separate units.
Another problem associated with some conventional blood glucose monitoring devices is that the user's blood physically contacts the elements within the testing unit. Cross-contamination can be a problem if the monitoring device is used by more than one user such as in a doctor's office or other clinical setting.
A lance is provided for puncturing skin and producing a sample of blood. The lance comprises a spring having a first end and a second end disposed between a needle and a base wherein the first end of integral spring is coupled to the base and the second end of the spring is coupled to the needle.
The above summary of the present invention is not intended to represent each embodiment, or every aspect, of the present invention. Additional features and benefits of the present invention will become apparent from the detailed description, figures, and claims set forth below.
Other objects and advantages of the invention will become apparent upon reading the following detailed description in conjunction with the drawings in which:
Referring now to
Referring also to
In operation, when a user is testing the glucose concentration of blood, the test sensor 202 remains stationary within a testing device while a force is imparted on to a top portion 236,238 of each force receiving member 232,234. The force receiving members 232,234 are driven downward thus forcing the needle 206 downward into the user's skin. Once the force is removed from the force receiving members 232,234, the spring 212 retracts the needle 206 from the user's skin.
Referring also to
A reagent is incorporated into the test sensor 202. The reagent is designed to react with the glucose in the blood which moves up the test area 240. The reaction produces a detectable signal which is indicative of the glucose concentration in the sample of blood. That signal is then measured by a sensor which can measure the concentration of the glucose in the blood based on the signal. The specific reagent incorporated into the test sensor 202 is a function of the type of sensing employed to determine the concentration of glucose in the blood. In the illustrated embodiment of the test sensor 202, electrochemical sensing is employed. The test sensor 202 includes a pair of electrodes 250 (FIG. 6). It electrochemical analysis, the change in current across the electrodes 250 caused by the reaction of the glucose and the reagent is indicative of the concentration of the glucose in the blood. The reaction of the glucose and the reagent creates an oxidation current at the electrodes 250 which is directly proportional to the user's blood glucose concentration. This current can be measured by an appropriate sensor coupled to a pair of terminals 252 corresponding to the electrodes 250 implemented in a glucose monitoring device for use with the sensor/lance 200. The glucose monitoring device can then communicate to the user the blood glucose concentration. An example of an electrochemical testing system is described in detail by commonly-owned U.S. Pat. No. 5,723,284 entitled "Control Solution and Method for Testing the Performance of an Electrochemical Device for Determining the Concentration of an Analyte in Blood" which is incorporated herein by reference in its entirety.
Referring now to
Referring now to
A blood glucose monitoring system 360 for use with the disposable end cap 350 having a sensor/lance 200 disposed therein is also illustrated in FIG. 8. The device 360 contains a switch 362 to activate the device 360. A trigger 364 is provided to fire a spring loaded plunger 366 to contact the force receiving members 232,234 which in turn provide movement to the needle 206. The when actuated, the spring loaded plunger 366 rapidly moves downward a predetermined distance to move the force receiving members 232,234 and in turn the needle 206 a predetermined distance causing the needle 206 to extend beyond a test end 352 of the end cap 350 a distance about equal to the needle 206 penetration depth. The distance that the needle 206 extends beyond the test end 352 of the end cap 350 is preferably a distance sufficient to draw a sample of blood for analysis. Once the plunger forces the needle downward, the spring loaded plunger 366 retracts a distance allowing the needle 206 to retract back within the bounds of the disposable end cap 350. Meanwhile, the sample of blood moves though the inlet 208 disposed adjacent to the test end 352 of the end cap 350) of the test sensor 202. Once the requisite blood sample has been obtained and the requisite time has elapsed for the reaction in the test sensor 202, the blood glucose monitoring system 360 measurers the signal produced by the reaction and determines the blood glucose concentration of the blood sample. The results of the analysis are communicated to the user via a display 368. The end cap 350 containing the used sensor/lance 200 is then removed from the system 300 and discarded. The end cap 350 and the blood glucose monitoring system 360 have suitable connectors 370, 372 for mating the end cap 350 with the blood glucose monitoring system 360.
Thus far, only electrochemical analysis to determine the glucose concentration of a blood sample has been discussed in conjunction with the present invention. However, the thin sensor/lance 203 of the present invention can be used with other types of blood glucose testing methods. For example, calorimetric testing may be implemented in the test sensor in conjunction with an alternative embodiment of the present invention. Colorimetric testing is described in commonly-owned U.S. Pat. No. 5,723,284 entitled "Control Solution and Method for Testing the Performance of an Electrochemical Device for Determining the Concentration of an Analyte in Blood," which was incorporated herein by reference above.
While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and will be described in detail herein. It should be understood, however, that it is not intended to limit the invention to the particular forms disclosed, but, to the contrary, the intention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
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